National Agency for Food and Drug Administration and Control (NAFDAC) on Wednesday said there are no records of Nigerian children dying or falling sick from exposure to a batch of Johnson & Johnson Benylin cough syrup.
NAFDAC announced a recall of the cough syrup after laboratory tests found an unacceptably high level of diethylene glycol, which is toxic to humans, prompting regulators in five other African countries also to issue recalls.
South Africa’s drugs authority said on Tuesday that the two batches of Benylin Paediatric Syrup it recalled had not caused any adverse reactions in South Africa or anyplace else in the world.
It stated that it was undertaking testing and investigations, as did manufacturer Kenvue, which now owns the brand following a spin-off from Johnson & Johnson last year.
“We hope to finalise these soon,” the South African Health Products Regulatory Authority told Reuters.
Consuming diethylene glycol can lead to acute kidney failure. Since 2022, the chemical has been linked to the deaths of dozens of children in Gambia, Uzbekistan, and Cameroon, in one of the world’s most severe episodes of oral medicine poisoning.
Fraden Bitrus, NAFDAC’s director of pharmacovigilance, told Reuters that the regulator tested the cough syrups in response to those deaths, rather than any specific report of harm to Nigerian children.
“We sampled several products. Some failed and some passed. This particular product had been sampled earlier, but we were not thinking of diethylene glycol, and because of this, we decided to test the product again,” he said.
The recalled batches of syrup were made by J&J in South Africa in May 2021.
Asked whether J&J was working with Kenvue to investigate what had gone wrong with the Benylin Paediatric Syrup, Joe Wolk, chief financial officer of J&J, told Reuters: “This is just with Kenvue at this point.”
Kenvue has said it is working with health authorities to determine next steps.
In addition to Nigeria and South Africa, regulators in Kenya, Tanzania, Rwanda and Zimbabwe have recalled the same batch of Benylin Paediatric Syrup.
